BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1585355 · Received January 19, 2010

    Report

    Report Number
    1823260-2010-00337
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 2, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MQM
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A NEWBORN SAMPLE WHICH INITIALLY RECOVERED A TOTAL BILIRUBIN RESULT OF 8.9 MG PER DL AND WAS REPORTED OUT OF THE LAB. A NURSE ON THE PEDIATRIC FLOOR QUESTIONED THE RESULT BECAUSE A MANUAL SKIN TEST FOR BILIRUBIN RESULTED IN 16 MG/DL. LAB REPEATED THE ORIGINAL SAMPLE ON (B) (6) 2010 WHICH RECOVERED 17.6 MG/DL. THIS REPEATED RESULT WAS NEAR THE CUTOFF FOR TREATMENT, THEREFORE, THE PT WAS REDRAWN TWICE ON (B) (6) 2010. FIRST RESULT WAS 20.9, SECOND RESULT WAS 17.5 MG/DL. AN ADD'L SAMPLE WAS DRAWN (B) (6) 2010 WHICH RECOVERED 14.5 MG/DL. ACCORDING TO THE CUSTOMER, NO TREATMENT WAS NECESSARY AND TREATMENT WAS NOT ALTERED OR WITHHELD DUE TO ERRONEOUS RESULTS. THE FIELD SERVICE REP DETERMINED A RINSE NOZZLE WAS DRIPPING WHICH CAUSED THE DISCREPANCY. HE CLEANED THE VALVE AND PERFORMED MECHANICAL CHECKS, PRECISION, CALIBRATION AND QC TO VERIFY ANALYZER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE MQM ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA